NCT06483516

Brief Summary

The treatment of AAA has been revolutionised by minimally invasive techniques that allow patients to return home more quickly and have a reputation for having a low impact on their quality of life. However, no study has looked at the quality of life of patients treated for AAA using open or endovascular surgery, using a scale adapted to post-operative follow-up. The investigators conducted a single-centre prospective observational study to assess the quality of life of patients undergoing AAA surgery by endovascular exclusion or open surgery

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2021

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2 days

First QC Date

June 21, 2024

Last Update Submit

July 1, 2024

Conditions

Post Operative Quality of Life After AAA Surgery

Outcome Measures

Primary Outcomes (1)

  • Quality of life evolution

    Qor15 score filled by the patient

    Day before surgery/ the day of discharge home (up to 1 month) / 1 month after surgery post operative consultation/ 6 months after surgery post operative consultation

Secondary Outcomes (3)

  • Post operative mortality

    day 30

  • early Reintervention

    Day 30

  • late reintervention

    3 months, 6 months, yearly

Study Arms (2)

OPEN REPAIR

Patient operated for AAA by conventional surgery

Procedure: Open repair

ENDO REPAIR

Patient operated for AAA by Endovascular exclusion (EVAR/F-BEVAR)

Procedure: Endovascular repair

Interventions

Open repairPROCEDURE

Open repair via median laparotomy or lumbotomy

OPEN REPAIR
Endovascular repairPROCEDURE

EVAR if AAA simple F-BEVAR if Complex AAA

ENDO REPAIR

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient to be operated on for an aneurysm of the abdominal aorta in scheduled surgery

You may qualify if:

  • Aortic abdominal aneurysm above 50mm

You may not qualify if:

  • Emergent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hostalrich

Toulouse, 31400, France

RECRUITING

MeSH Terms

Interventions

Endovascular Aneurysm Repair

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeBlood Vessel Prosthesis ImplantationVascular GraftingMinimally Invasive Surgical ProceduresProsthesis Implantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 21, 2024

First Posted

July 3, 2024

Study Start

January 1, 2021

Primary Completion

January 3, 2021

Study Completion

December 30, 2025

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

FR(1)